FDA Registration
Active
🇲🇾 Malaysia
NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)
Reg #: 3014164734
·
FEI: 3014164734
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- CAREGLOVE GLOBAL SDN BHD
- Registration Number
- 3014164734
- FEI Number
- 3014164734
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 17479, Lorong Senawang 3/2,, Off Jln Senawang 3, Senawang Ind Estate
- City
- Seremban Negeri Sembilan
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K230121
Owner / Operator
- Firm Name
- Careglove Global Sdn Bhd
- Operator Number
- 10051431
- Address
- Lot 17479, Lorong Senawang 3/2,, Off Jln Senawang 3, Senawang Ind Estate
- City
- Seremban
- State
- Negeri Sembilan
- Postal Code
- 70450
- Country
- MY
- Correspondent
- Kwee Shyan Lim
US Agent
- Business Name
- Liberty Management Group Ltd.
- Contact Name
- Manoj Zacharias
- Address
- 75 Executive Drive,, Suite 114,
- City
- Aurora
- State
- IL
- ZIP
- 60504
- Country
- US
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2023-05-16 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-05-16 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2023-05-16 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2023-05-16 |
Proprietary Names
NITRILE EXAMINATION GLOVES POWDER FREE TESTED FOR USE WITH CHEMOTHERAPY DRUGS & FENTANYL CITRATE (BLUE & BLACK)
Establishment Types
Manufacture Medical Device